Kornimate/medical-research-clean huggingface dataset:
microwave ablation versus laparoscopic hepatectomy for 3-5cm hepatocellular carcinoma

Conditions: Overall Survival; Progression-free Survival; Cost

Summary: as the most common subtype of liver cancer (85% \~ 90%), hcc is highly malignant; thus, one of the crucial issues in hcc management is an effective therapy for tumors at an early stage, which is vital for improving the prognosis of patients. for ≤3cm hcc, ablation has been recommended by international guidelines as a first-line or alternative treatment because of similar survival outcomes and milder liver function injury with liver resection (lr). however, the appropriate treatment options for 3-5cm hcc remain controversial. thus, none of the international guidelines recommend ablation as a first-line treatment for 3-5cm hcc. in the past few decades, treatment for hcc has tended to be less invasive, have fewer complications, and have higher cost-effectiveness. compared with lr, laparoscopic hepatectomy (lh) demonstrates the advancement of minimal invasion. as another minimally invasive technique for hcc, microwave ablation (mwa) has the potential to eradicate larger hccs with larger coagulation areas and is less affected by the heat sink effect caused by vessels around the tumor. many studies have identified the potential advantages of mwa over other ablation techniques. however, to date, no clinical studies have compared the efficacy of lh and mwa therapies for 3-5cm hcc with periodic progression.


Eligibility criteria:
inclusion criteria: i) age ≥18 years ii) all patients with an initial diagnosis of 3-5cm hcc(within 3 tumors, at least one 3-5cm) by histopathology iii) child-pugh class a or b iv) no vascular invasion or distant metastasis v) no other malignant neoplasms within the last 5 years exclusion criteria: i) age \<18 years ii) child-pugh class ≥b iii) vascular invasion or distant metastasis iv) with other malignant neoplasms within the last 5 years
hpv in sinonasal ca: retrospective analysis association of human papilloma virus (hpv) serology and behavioral risk factors

Conditions: Sinonasal Carcinoma; HPV-Related Squamous Cell Carcinoma

Summary: this is a case-control study designed to evaluate the role of anatomic site, gender and race in human papillomavirus-associated head and neck squamous cell cancers (hnscc). we will explore the role of hpv, tobacco, alcohol and drug use, in hnscc by tumor site with particular emphasis on the sinonasal cavity as well as differences in risk factors for hpv-positive hnscc by gender and race.


Eligibility criteria:
inclusion criteria: * cases: * patients must be 18 years of age or older with a confirmed or suspected diagnosis of sinonasal cancer * patients must have either a routine diagnostic biopsy of primary tumor or surgical resection planned as part of routine care (to allow for the collection of tumor sample for the study) or grant access to archival material, from a previously performed biopsy. * willing to provide 20 ml blood sample * ability to understand and the willingness to sign a written informed consent document * controls: * must be 18 years of age or older within the categories of age, gender, and race needed to match cases * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * cases: * presence of medical or psychiatric condition affecting ability to give voluntary, informed consent * participants who do not speak english and do not agree to use of a telephone or video interpreter will be excluded. however, if there is a hearing, literally or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked * controls: * presence of medical or psychiatric condition affecting ability to give voluntary, informed consent * participants who do not speak english and do not agree to use of a telephone or video interpreter will be excluded. however, if there is a hearing, literacy or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked * no prior diagnosis of head and neck cancer, except basal cell cancer * no previous radiation therapy of the head and neck
prospective effectiveness and safety study of cladribine in participants who change first-line dmd treatments for multiple sclerosis (clad cross)

Conditions: Multiple Sclerosis

Summary: the main aim is to study in the real world setting the effectiveness of cladribine tablets in terms of annualized relapse rate (arr) and disability progression, in participants who switched from a first line disease modifying drug (dmd) (interferons, glatiramer acetate, teriflunomide, (dymethyl fumarate) \[dmf\]) to treatment with cladribine tablets in routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants with confirmed diagnosis of rrms diagnosed by the treating physician according to applicable clinical practice guidelines -(currently mcdonald 2017 criteria), with high disease activity * participants should have been treated with the same first-line dmd (interferons, glatiramer acetate, teriflunomide, dmf) and at a stable dose for at least one year prior to switch to cladribine tablets and should have been prescribed cladribine tablets, according to the decision of the treating physician, prior to enrollment in the study. any washout period and/or washout methods required before switching (such as elimination of teriflunomide) must have been conducted, according to the decision of the treating physician * required history data should be available: multiple sclerosis (ms) data for the 12-months pre-baseline period (annualized relapse rate); ms medication history (prior dmds) * fulfilment of the criteria for treatment with cladribine tablets per standard of care in accordance with the local summary of product characteristics (smpc) exclusion criteria: * contraindications to use of cladribine tablets according to the smpc * participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study * participants that have received cladribine in the past * concurrent participation in an investigational study in which participant assessment and/or treatment may be dictated by a protocol

Keywords: multiple sclerosis cladribine mavenclad ®
a study to analyze the role of sympathetic nervous system in spontaneous coronary artery dissection

Conditions: Spontaneous Coronary Artery Dissection; Healthy

Summary: the purpose of this research is to compare sympathetic function (flight or fight system) and arterial health including structure and mechanics of participants with history of spontaneous coronary artery dissection (scad) to age and sex matched control participants.


Eligibility criteria:
inclusion criteria: * for scad patients: history of scad as confirmed by coronary angiography or cardiac computed tomography angiography * for controls: no cardiac disease history exclusion criteria: * pregnancy * known or suspected unstable cardiac condition within 4 weeks of the study * active treatment with anticoagulation or dual antiplatelet therapy * prisoner
prinomastat plus temozolomide following radiation therapy in treating patients with newly diagnosed glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: prinomastat may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die. purpose: randomized phase ii trial to study the effectiveness of prinomastat plus temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.

objectives: i. compare the one year survival rate and progression free survival of patients with newly diagnosed glioblastoma multiforme treated with prinomastat (ag3340) or placebo and temozolomide following radiotherapy. ii. compare the safety of these regimens in these patients. iii. compare the quality of life in these patients on these regimens. outline: this is a randomized, double blind, placebo controlled, multicenter study. patients receive oral prinomastat or placebo twice daily in combination with oral temozolomide daily on days 1-5. treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. projected accrual: approximately 100 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: newly diagnosed glioblastoma multiforme must have completed all appropriate subtotal or total surgical procedures (surgical biopsy alone not eligible) must have received prior external beam radiotherapy no multifocal glioblastoma multiforme no radiographic disease progression during post surgical radiotherapy patient characteristics: age: 16 and over performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: stable steroid therapy for at least 2 weeks prior to study radiotherapy: see disease characteristics no prior interstitial brachytherapy or radiosurgery surgery: see disease characteristics no prior radiosurgery

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
mindfulness-based dementia care partner program to reduce depressive symptoms

Conditions: Dementia

Summary: the purpose of this study is to assess the feasibility, acceptability, and fidelity of implementation of the mindfulness based dementia care (mbdc) program to reduce depressive symptoms in care partners (cps) of people living with dementia (plwd).


Eligibility criteria:
inclusion criteria: * age ≥18 years * self-identify as being an informal cp providing caregiving to a plwd * register for an mbdc course through the presence care website exclusion criteria: * previous participation in an mbdc program. * does not speak and understand either english or spanish.

Keywords: caregivers mindfulness
gait pattern comparison of cruciate-retaining and posterior-stabilized arthroplasties

Conditions: Knee Osteoarthritis

Summary: in total knee arthroplasty (tka), the posterior-cruciate ligament-retaining (cr) and posterior-cruciate-ligament stabilized (ps) techniques are widely used depending on the individual preference of the surgeon. comparative analysis of these two techniques is a major topic of investigation in arthroplasty research. the hypothesis of the present study is that compared with the cr technique, the ps technique is associated with a worse gait pattern. smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing total knee arthroplasty with a cr and a ps technique, at 3, 6, and 12 months postoperatively.

patients undergoing total knee arthroplasty are randomized to posterior-cruciate ligament-retaining (cr) and posterior-cruciate-ligament stabilized (ps) groups by generating random numbers with microsoft excel. the patients are/will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (kss and koos), life quality (sf-12), and smart-phone based gait analysis. all data will be calculated as mean and standard deviation values. the student's t-test will be used for statistical analysis of the patient data. statistical calculations will be performed using spss vn.22.0 software (ibm spss statistics for windows, version 22.0. armonk, ny, usa).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of unilateral primary knee osteoarthritis * age 55 to 85 years * must be able to walk without support exclusion criteria: * rheumatological joint diseases * previous knee surgery * neuromuscular diseases * bilateral knee osteoarthritis * insufficiency of knee collateral ligaments.

Keywords: knee arthroplasty gait analysis smart-phone
quantification of upper extremity use and effects of feedback in the home setting

Conditions: Feedback Intervention (Participants Post-stroke); Healthy Control

Summary: a pilot study, the purpose of which is to use accelerometers to quantify ue use (1 and two hand use) in healthy controls and people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. the objectives of this pilot study are to: i.) determine the feasibility of using accelerometers to quantify amount of ue use in the home setting in healthy individuals and individuals chronic post-stroke, ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) ues, iii.) quantify and compare amount of ue use in healthy controls to that of people chronic post-stroke (side matched unimanual use for each arm and bilateral use) in the home, and iv.) assess the effect of a few sessions of in-home accelerometer used-based feedback on unilateral and bilateral ue use. v.) assess kinematic, kinetic, and emg data during ue movements bilaterally and between healthy controls and subjects post-chronic stroke pre and post feedback (for the people after stroke).


Eligibility criteria:
inclusion criteria: * healthy adults: 40-100 years old, able to follow 2-step commands, able to comply with experimental protocol, living in a home setting, full active range of motion (arom) in both shoulders and elbows for their age group. * individuals post-stroke: able to follow 2-step commands, 40 - 100 years old, community dwelling with or without assistance, no upper extremity (ue) injury within the last 3 months, at least 30 degrees of flexion arom (with or without assistance) and prom in shoulder and elbow in or out of synergy, intact superficial light touch sensation in both ues, and at least 6 months post ischemic or hemorrhagic stroke that is either cortical, subcortical or in the cerebellum. it does not need to be their first and only stroke. exclusion criteria: * healthy adults: injury of either ue within the last 3 months and unable to follow commands related to the accelerometer use/protocol. * individuals post-stroke: unable to follow 2 step commands, inability to adhere to study requirements, any neurological diagnosis other than stroke (i.e. parkinson's disease, multiple sclerosis, etc.), and aphasia limiting their ability to complete the moca and stroke impact scale (sis) questions.
cost-effectiveness study in the reduction of coronary restenosis with sirolimus-eluting stents

Conditions: Coronary Artery Disease

Summary: since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. they consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis. the study "prevention of coronary restenosis" examines the effectiveness of sirolimus-eluting stents (ses) compared to bare-metal stents (bms) in patients with coronary stenosis. the goal of the study is to examine whether the guideline-supported implantation of ses, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. secondarily, the study evaluates patient quality of life, impairment of daily activities, re-intervention rate, as well as an account of the utilisation and benefits of the implemented standardised guidelines. in this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an implantation of a ses for treatment of coronary stenosis were recruited from 35 hospital centres. their treatment and outcomes will be evaluated over a 3-year period by means of standardised questionnaires. in addition, information obtained from the patients will be confirmed and augmented by telephone interviews with the attending physicians involved in their follow-up care. in order to appraise the effect of the new therapy, a comparison cohort group of 394 patients receiving a bms was recruited. these patients will be evaluated and observed by the same method as those patients receiving a drug-eluting stent, also over 3 years


Eligibility criteria:
inclusion criteria: * indication for implantation of a coronary stent * de novo lesions \< or = 30 mm in patients with diabetes * de novo lesions 12-30 mm or rvd 2.5-3.00 mm in patients without diabetes exclusion criteria: * acute mi * lesion length \>30 mm * in-stent restenosis * distal lesion in rvd \< 2.25 mm * lesion in left main or bypass vessel * contraindication to clopidogrel

Keywords: drug-eluting stents
neutrasal treatment for xerostomia in osas patients using cpap therapy

Conditions: Xerostomia

Summary: to assess whether the daily use of neutrasal will prevent or reduce dry mouth in patients undergoing cpap therapy for osas and improve cpap compliance

subjects diagnosed with obstructive sleep apnea syndrome (osas) who have started cpap treatment and have complained of dry mouth or developed worsening of a pre-existing dry mouth as an effect of cpap treatment will test the effectiveness of neutrasal mouthwash in preventing or reducing his/her dry mouth perceptions and improving their compliance with cpap.

Eligibility criteria:
inclusion criteria: * patient should be above 18 years of age. * patients who have been initiated on cpap therapy after an initial diagnosis of osas and have developed dry mouth or have worsening of pre-existing dry mouth condition, as an effect of cpap therapy. * ability to attend visits at the research site * patient should be able to read and/or understand and sign the consent form be willing to participate in the research study exclusion criteria: * patients with open mouth sores at study entry. * any pathology that, based on the judgement of the researcher, could negatively affect the oral mucosa and subsequent treatment for xerostomia (immune disorders, etc.) * patients using any other prophylactic mouthwashes. * patients who are pregnant and/or nursing. * patients becoming pregnant during the treatment period will be removed from data. * patients on a low sodium diet * patients currently on medication or treatment for xerostomia * patients \< 18 years of age * hypersensitivity to any of the following ingredients- sodium chloride, sodium phosphate, calcium chloride and sodium bicarbonate

Keywords: obstructive sleep apnea syndrome
diabetes knowledge assessment

Conditions: Type 2 Diabetes Mellitus

Summary: to assess the knowledge of both type 2 diabetics and non-diabetics on diabetes, nutrition, and exercise. although type 2 diabetics should know more about their disease and its needs, it is not expected they will know significantly more than the lay public.

a validated survey about diabetes, nutrition, obesity, and exercise will be dispersed to type 2 diabetics and non-diabetics, and then analyzed.

Eligibility criteria:
inclusion criteria: type 2 diabetic or non-diabetic, age 18 and over exclusion criteria: type 1 diabetic
gemcitabine and docetaxel therapy in high-risk bcg-naive patients with non-muscle invasive bladder cancer

Conditions: Non-muscle-invasive Bladder Cancer

Summary: bacillus calmette-guerin (bcg) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (nmibc) after transurethral tumor resection. since 2012, global bcg shortage encouraged the search of alternative treatment for nmibc treatment. intravesical gemcitabine and docetaxel chemotherapy (gem/doce) has shown safety and efficacy in 2 retrospective, single institution cohorts. at our institution, gem/doce has been offered as an option for nmibc in the treatment of high-risk bcg-naive patients per the protocol adapted from university of iowa, in shortage situation. our objective is to evaluate the efficacy of gem/doce therapy.


Eligibility criteria:
inclusion criteria: * bcg-naive patients with high-risk non-muscle invasive bladder cancer exclusion criteria: * patients in whome cystectomy is planned
protocol for herceptin as adjuvant therapy with reduced exposure to chemotherapy (phare-c)

Conditions: HER2-positive Breast Cancer

Summary: rationale: according to previous results from phare study, a subgroup of patients with low-risk cancer (\< 3 cm) without axillary lymph node involvement or small (\< 2 cm) with minimal lymph node involvement (1 positive node) presented low risk of recurrence. maintaining chemotherapy in this subgroup could cause toxicity and it is not yet known whether giving trastuzumab as monotherapy in neoadjuvant setting is as effective as giving trastuzumab combined with paclitaxel in patients with low risk early breast cancer. purpose: this randomized phase iii trial is studying trastuzumab as monotherapy in neoadjuvant setting to see if this treatment regimen is as efficient compared to trastuzumab combination with paclitaxel chemotherapy in treating women with low risk (tumor size\< 3 cm, n0) early breast cancer.

phare-c is an open-label, randomized, phase iii, non-inferiority trial, that will recruit patients with human epidermal growth factor receptor 2 (her2)-positive early breast cancer to allow for comparison of neoadjuvant treatment with paclitaxel plus trastuzumab versus trastuzumab as monotherapy. non-inferiority between the two treatment arms will be evaluated in terms of time to progression as primary objective. treatment tolerance and cardiac toxicity will be assessed as secondary objectives. in case of non pcr, a rescue by trastuzumab emtansine (t-dm1) is planned to control the survival outcome.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the breast, nonmetastatic disease and non operated tumor * without suspicious axillary nodes * tumor size \< 30 mm * eligibility to receive a weekly paclitaxel based chemotherapy for this cancer * left ventricular ejection fraction (lvef) obtained and \> 50% as measured by echocardiography (simpson method) or multigated acquisition scan (muga) at 3 months (-/+ 1 month) * overexpression of her-2 in the invasive component of the primary tumor as indicated by one of the following: 3+ by immunohistochemistry (ihc) 2+ by ihc and confirmation by fluorescent in situ hybridization (fish) or chromogenic in situ hybridization (cish) * with signed informed consent exclusion criteria: * previous anti-her2 treatment (except for herceptin) * cardiac disease or other medical conditions preventing trastuzumab administration * known allergy to trastuzumab, murine proteins or other excipients * pregnant or breastfeeding women * patients that are not able to comply to the protocol assessments for geographic, social or psychological reasons